Epic™ Vascular H74939200124020Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent System · Class 3
All models of Epic Vascular (50)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805144), received between Feb 21, 2023 and Sep 4, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device2
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600727 ↗MalfunctionAug 21, 2024Defective Device; Defective Device
IT WAS REPORTED THAT PROFILE PROBLEM OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 12X40X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, IT WAS DETERMINED BY THE STENT MARKER THAT THE LENGTH OF THE STENT WAS INSUFFICIENT FOR THE LENGTH OF THE LESION, THEREFORE THE SIZE WAS CHANGED. THE PROCEDURE WAS COMPLETED BY PLACING A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20017972 ↗MalfunctionFeb 21, 2023Defective Device; Defective Device
IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE PATIENT PRESENTED WITH LOWER EXTREMITY ARTERIAL DISEASE (LEAD). THE 99% STENOSED, 13 TO 14CM IN LENGTH, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC VESSEL. AFTER THE 6F NONBOSTON SCIENTIFIC (BSC) SHEATH WAS INTRODUCED AND NONBSC GUIDEWIRE CROSSED THE LESION, A 12 X 40 X 120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WAS SHORTENED AND WAS UNABLE TO COVER THE LESION. ANOTHER 12 X 60 X 120 EPIC VASCULAR STENT WAS THEN PLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16409605 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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